HEALTH-RELATED QUALITY OF LIFE (HRQOL) AND COLORECTAL CANCER (CRC) SYMPTOMS IN METASTATIC CRC- PANITUMUMAB PLUS BEST SUPPORTIVE CARE (BSC) VS. BSC ALONE BY KRAS TUMOR STATUS
Author(s)
Down Odom, MS, Research Statistician1, Giovanna Devercelli, MBA, PhD, Director, Global Health Economics2, Lee Bennett, MS, Research Statistician1, Marc Peeters, MD, PhD, Prof. Dr3, Michael Wolf, PhD, Director, Biostatistics2, Rafael Amado, MD, Executive Director Global Development21RTI Health Solutions, Research Triangle Park, NC, USA; 2 Amgen, Thousand Oaks, CA, USA; 3 Ghent University Hospital, Ghent, Belgium
OBJECTIVES: Panitumumab, a fully human anti-EGFr monoclonal antibody, is approved in Europe as monotherapy for mCRC patients with wild-type (non-mutated) KRAS tumors. In a randomized phase 3 trial, chemorefractory mCRC patients receiving panitumumab plus BSC had significantly longer progression-free survival vs. BSC alone. Analyses of the KRAS gene showed that all responders had wild type KRAS. This analysis evaluates patient-reported outcomes (PROs) by KRAS status. METHODS: In the phase 3 trial, mCRC patients with disease progression after standard chemotherapy were randomized 1:1 to panitumumab (6mg/kg Q2W) plus BSC vs. BSC alone. KRAS status was assessed in 427/463 (92%) patients. Analyses of PROs included HRQOL (EQ-5D) and CRC symptoms (NCCN/FACT CRC Symptom Index, FCSI). Linear mixed models estimating change from baseline in PRO scores were employed. Sensitivity analysis using pattern-mixture models evaluated the appropriateness of the assumption that PRO data were missing at random. Pattern-mixture models can provide unbiased estimates of treatment effects, taking into account missing data patterns. ANCOVA of the time-adjusted AUC using last value carried forward (LVCF) and slope imputation methods were also used. RESULTS: There were 363/427 (85%) patients in the KRAS-PRO analysis set (188 panitumumab [112 wild-type KRAS; 76 mutant KRAS]; 175 BSC [96 wild-type KRAS; 79 mutant KRAS]). Linear mixed models showed significant differences in CRC symptoms and HRQOL in favor of panitumumab in patients with wild-type KRAS. No differences were observed in patients with mutant KRAS. Pattern-mixture analysis showed that significant differences in CRC symptoms (FCSI scores: difference in LS adjusted means [95%CI]; 5.746 [1.448, 10.044] and HRQOL (EQ-5D scores: difference in LS adjusted means [95%CI]; 0.319 [0.184, 0.454]) in favor of panitumumab treated patients with wild-type KRAS were particular to patients who progressed greater or equal to 9 weeks. CONCLUSIONS:Panitumumab patients with wild-type KRAS showed significantly better HRQOL and CRC symptoms compared to BSC alone.
Conference/Value in Health Info
2008-11, ISPOR Europe 2008, Athens, Greece
Value in Health, Vol. 11, No. 6 (November 2008)
Code
PCN87
Topic
Patient-Centered Research
Topic Subcategory
Patient-reported Outcomes & Quality of Life Outcomes
Disease
Oncology